Method: PRE-ACT (PReparatory Education About Clinical Trials) is a web-based educational tool designed to increase cancer patients’ preparation for making decisions about clinical trial enrollment by delivering video content tailored to individuals’ knowledge gaps and attitudes assessed by baseline survey. We conducted a multicenter, randomized study of PRE-ACT vs. written generic clinical trials information. The baseline survey (5-point Likert scales) included questions regarding cost concerns: “How much of a burden on you is the cost of your medical care? (Q1)”, “I'm afraid that my health insurance won't pay for a clinical trial (Q2),” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial (Q3).” We summed results, with higher scores indicating greater financial concerns. Multiple linear regression was used to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress and decisional conflict in separate models, controlling for sociodemographic characteristics. In secondary analyses, similar models were built using the cost questions (Q2 and 3) together and burden (Q1) alone.
Result: 1212 patients completed baseline surveys. 27% were 65 or older. 58% were female. 24% had high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, and greater decisional conflict and distress, even after adjustment for age, race, gender, education, employment and hospital location (p<.0001 for all models). In the self-efficacy, preparation and distress models, age < 65, unemployment and lack of education past high school were also significantly associated with greater concerns (p<.05 for all models) . Similar findings were noted for secondary analyses, except that greater burden (Q3) was not associated with worse self-efficacy.
Conclusion: Financial concerns are associated with several psychological constructs that may negatively impact informed decision-making regarding clinical trial participation. Greater attention to patients’ financial needs and available resources may best help them make optimal treatment decisions that reflect their preferences and values.